Representation and reporting of kidney disease in cerebrovascular disease: A systematic review of randomized controlled trials.
Representation and reporting of kidney disease in cerebrovascular disease: A systematic review of randomized controlled trials.
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DOI：
10.1371/journal.pone.0176145
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发表时间：
2017
期刊：
影响因子：
3.7
通讯作者：
Nadkarni GN
中科院分区：
文献类型：
--
作者：
Konstantinidis I;Patel S;Camargo M;Patel A;Poojary P;Coca SG;Nadkarni GN
患有肾脏疾病（KD）的患者患脑血管疾病（CVD）的风险增加，而患有KD的CVD患者的结局更差。我们的目的是确定KD患者在CVD干预的主要随机对照试验（RCT）中的代表性。我们在MEDLINE中检索了截至2017年2月9日发表的主要CVD试验报告。我们排除了未报告死亡率结局、入组人数少于100人、或为亚组、随访或事后分析的试验。两名独立的评审员进行研究选择和数据提取。我们纳入了135项随机对照试验，随机分配了194，977名受试者。KD患者在48项（35.6%）试验中被排除，但不太可能从I/II类推荐干预措施试验中被排除（n = 7; 15.9%; p = 0.001），而更可能在注册方案试验中被排除（45.5% vs. 22.4%; p = 0.007）。与行业或联合资助相比，学术或政府赠款的试验排除率较低（21.2% vs. 42.0%和47.8%; p = 0.033和0.028）。在排除KD患者的试验中，24项（50.0%）使用血清肌酐，7项（14.6%）使用估计的肾小球滤过率或肌酐清除率，7项（14.6%）使用肾脏替代治疗，19项（39.6%）使用非特异性肾脏相关标准。仅4项（3.0%）试验报告了基线肾功能。没有试验预先规定或报告按基线肾功能进行的亚组分析。尽管19项（14.1%）试验报告了急性肾损伤的发生率，但没有试验根据肾功能检查不良事件发生率。总之，超过三分之一的主要CVD试验排除了KD患者，主要基于血清肌酐或非特异性标准，结局未按肾脏参数分层。因此，需要有目的地努力增加CVD试验中KD患者的纳入，并评估肾功能对疗效和安全性的影响，以提高这一弱势人群干预措施的证据质量。
Patients with kidney disease (KD) are at increased risk for cerebrovascular disease (CVD) and CVD patients with KD have worse outcomes. We aimed to determine the representation of KD patients in major randomized controlled trials (RCTs) of CVD interventions. We searched MEDLINE for reports of major CVD trials published through February 9, 2017. We excluded trials that did not report mortality outcomes, enrolled fewer than 100 participants, or were subgroup, follow-up, or post-hoc analyses. Two independent reviewers performed study selection and data extraction. We included 135 RCTs randomizing 194,977 participants. KD patients were excluded in 48 (35.6%) trials, but were less likely to be excluded from trials of class I/II recommended interventions (n = 7; 15.9%; p = 0.001) and more likely to be excluded in trials with registered protocols (45.5% vs. 22.4%; p = 0.007). Exclusion was lower in trials supported by academic or governmental grants compared to industry or combined funding (21.2% vs. 42.0% and 47.8%; p = 0.033 and 0.028, respectively). Among trials excluding KD patients, 24 (50.0%) used serum creatinine, 7 (14.6%) used estimated glomerular filtration rate or creatinine clearance, 7 (14.6%) used renal replacement therapy, and 19 (39.6%) used non-specific kidney-related criteria. Only 4 (3.0%) trials reported baseline renal function. No trials prespecified or reported subgroup analyses by baseline renal function. Although 19 (14.1%) trials reported the incidence of acute kidney injury, no trial examined adverse event rates according to renal function. In summary, more than one third of major CVD trials excluded patients with KD, primarily based on serum creatinine or non-specific criteria, and outcomes were not stratified by renal parameters. Therefore, purposeful efforts to increase inclusion of KD patients in CVD trials and evaluate the impact of renal function on efficacy and safety are needed to improve the quality of evidence for interventions in this vulnerable population.